Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022399
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2001-08-10
Brief Title:
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Randomized Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate Evaluation Of Drug-Specific Biomarker Modulation
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Celecoxib may be an effective treatment for early stage prostate cancer It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer
PURPOSE Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer
PURPOSE Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer
Detailed Description:
OBJECTIVES
Compare biomarker modulation prostaglandin levels in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy
Compare the effect of these regimens on angiogenic factors within the prostate in these patients
Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients
Compare the toxicity profiles of these regimens in these patients
Compare the compliance of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral neoadjuvant celecoxib twice daily
Arm II Patients receive oral neoadjuvant placebo twice daily Treatment in both arms continues for at least 4 weeks followed by prostatectomy
Patients are followed within 1 month and then at 3 months
PROJECTED ACCRUAL A total of 60-70 patients at least 30 per arm will be accrued for this study
Compare biomarker modulation prostaglandin levels in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy
Compare the effect of these regimens on angiogenic factors within the prostate in these patients
Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients
Compare the toxicity profiles of these regimens in these patients
Compare the compliance of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral neoadjuvant celecoxib twice daily
Arm II Patients receive oral neoadjuvant placebo twice daily Treatment in both arms continues for at least 4 weeks followed by prostatectomy
Patients are followed within 1 month and then at 3 months
PROJECTED ACCRUAL A total of 60-70 patients at least 30 per arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P01-0186 | Other Identifier | JHM IRB | httpsreporternihgovquickSearchP30CA006973 |
| P50CA058236 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| CDR0000068812 | None | None | None |
| 00-03-08-01 | OTHER | None | None |
| NCI-N01-95129 | None | None | None |